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Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Background
Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects.
Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions).
It remains unknown, however, which of these two therapeutic approaches is more effective after PCI.
Purpose
The primary objective of this study is to compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe | Active Comparator | Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day) |
|
| Nutraceuticals | Active Comparator | Patients assigned to nutraceuticals will receive for 1 year 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug | os, 10 mg, once daily, 1 year |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of treatment tolerability | Reasons for treatment discontinuation | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of drug effects on lipid and metabolic features | Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA) | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Pelliccia, MD | Contact | +393483392006 | f.pelliccia@mclink.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Pisana | Recruiting | Rome | 00100 | Italy |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nutraceuticals | Drug | os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year |
|
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D005502 |
| Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |